The American Herbal Products Association (AHPA) highlights serious flaws in the rationale of a Citizen Petition requesting that the Food and Drug Administration (FDA) treat weight loss claims for dietary supplements as disease claims in comments filed with the agency Oct. 7.
"FDA has correctly ruled that claims are allowed for supplements that may have a benefit in assisting normal and overweight persons to lose weight, and that claims for treatment of the disease of obesity are not allowed,” said AHPA President Michael McGuffin. “The petitioners’ argument that FDA was unaware of information presented in their petition when it developed the existing rule is unsupported. It should also be noted that the petition relies to a large degree on data from a consumer survey that had significant flaws in its design, and that has been poorly interpreted by the petitioners,” he added.
GlaxoSmithKline Healthcare (GSK), the marketer of non-prescription weight-loss drug Alli®, filed the petition April 17 along with the American Dietetic Association, the Obesity Society and Shaping America’s Health. The petitioners claim that being overweight, while not a disease in and of itself, is a significant risk factor for other serious diseases. They request that FDA ban dietary supplements from making weight loss claims as structure/function claims under the Dietary Supplement Health and Education Act, and instead require dietary supplement weight loss claims to be limited to FDA-approved health claims. But the petition also states there is no evidence to support such a health claim, so the effect of granting the Petition could be to provide GSK’s Alli® with a monopoly in the U.S. over-the-counter weight loss market. .
“If FDA granted this petition it would contravene Congressional intent and public policy, and would be unconstitutional under the First Amendment,” said AHPA’s McGuffin. “AHPA requests that FDA deny the petition.”
AHPA’s full comments are available here: www.ahpa.org/portals/0/pdfs/08_1007_AHPA_Comments_GSK_Petition.pdf
The GSK petition is also available online: www.ahpa.org/portals/0/pdfs/GSK_Petition_FDA-2008-P-0248-0001.pdf
The American Herbal Products Association (AHPA) is the only national trade association devoted to herbal issues. Representing the core of the botanical trade—comprised of the finest growers, processors, manufacturers and marketers of herbal products—our mission is to promote the responsible commerce of herbal products. AHPA committees generate self-regulations to ensure the highest level of quality with respect to the way herbal products are manufactured, labeled, and sold. Website: www.ahpa.org.